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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV Back to Search Results
Catalog Number 1491860UVUS
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 10/12/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, the customer reported to leica biosystems that patient tissue was undiagnosable due to sectioning issues with the instrument leica cm1860. Leica biosystems requested additional information regarding the event; however, the customer declined to provide any additional details or information regarding the undiagnosable patient tissue. Furthermore, the customer provided the following email response to leica biosystems on 18 october 2021, "in following up with our risk team we are submitting smda so you will be able to get that information through that system" and "at this time we will decline to provide further details at the recommendation of our risk department. " if leica biosystems receives additional information, a follow up report will be submitted.
 
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Brand NameLEICA CM1860UV
Type of DeviceLEICA CM1860UV
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstrasse 17-19
nussloch, 69226
GM 69226
MDR Report Key12796493
MDR Text Key282205677
Report Number1423337-2021-00013
Device Sequence Number1
Product Code IDP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1491860UVUS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2021
Distributor Facility Aware Date10/12/2021
Event Location Other
Date Report to Manufacturer11/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/11/2021 Patient Sequence Number: 1
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